510(k) K882916

MOTORIZED PARALLEL BAR, MODEL 110 by Tri W-G, Inc. — Product Code BXB

K882916 is an FDA 510(k) premarket notification submitted by Tri W-G, Inc. for the device "MOTORIZED PARALLEL BAR, MODEL 110". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Tri W-G, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
July 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type